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Date Printed: June 28, 2017: 11:57 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-44

Original Effective Date: 01/01/12

Reviewed: 08/10/16

Revised: 12/15/16

Subject: Erlotinib (Tarceva®) Tablets

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Erlotinib (Tarceva®) is an oral, selective epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). EGFR is expressed, overexpressed or dysregulated in a variety of cancers including breast cancer, non-small cell lung cancer (NSCLC), and ovarian cancer. Erlotinib was initially approved by the US Food and Drug Administration for the treatment of NSCLC in 2004. In 2005, the approval was expanded to include treatment of pancreatic cancer. Current National Comprehensive Cancer Network guidelines support the use of erlotinib in the treatment of NSCLC, pancreatic, and chordoma.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of erlotinib (Tarceva®) meets the definition of medical necessity for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Bone Cancer-Chordoma

a. Member has recurrent disease

b. Erlotinib is used as monotherapy

c. Dose does not exceed 150 mg/day – dosage will be achieved using the fewest number of tablets per day

2. Non-Small Cell Lung Cancer AND known sensitizing epidermal growth factor receptor mutation

a. Member has a documented epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation as detected by an FDA-approved test – laboratory documentation must be provided

b. Member has recurrent or metastatic disease

c. One of the following:

i. Erlotinib will be used as first line therapy

ii. Erlotinib will be used as subsequent therapy following disease progression on erlotinib for any of the following:

1. Asymptomatic disease

2. Symptomatic brain lesions

3. Isolated symptomatic systemic lesions

d. Erlotinib will be used as monotherapy

e. Dose does not exceed 150 mg/day – dosage will be achieved using the fewest number of tablets per day

f.

3. Pancreatic Adenocarcinoma

a. Member has locally advanced, unresectable, or metastatic disease

b. Erlotinib will be used in combination with gemcitabine (Gemzar®)

c. Dose does not exceed 100 mg/day – dosage will be achieved using the fewest number of tablets per day

4. Kidney Cancer

a. Member meets one of the following:

i. Member’s disease is relapsed

ii. Member’s disease is stage IV AND medically or surgically unresectable

b. Use is in disease with non-clear cell histology

c. Erlotinib will be used as first-line therapy

d. Erlotinib will be used as monotherapy

e. Dose does not exceed 150 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 6 months

Continuation of erlotinib (Tarceva) meets the definition of medical necessity when ALL of the following criteria are met:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years, OR the member currently meets all indication-specific initiation criteria.

2. Member has a known EGFR-sensitizing mutation (NSCLC) OR member’s disease has not progressed during treatment with erlotinib

3. Dose does not exceed 150 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 1 year

Erlotinib meets the definition of medical necessity when used to treat the following designated Orphan Drug indication when the dose does not exceed the maximum FDA-approved dose:

1. Malignant gliomas

Approval duration: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: erlotinib is indicated for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. The recommended dose is 150 mg once daily for the treatment of NSCLC and 100 mg once daily for pancreatic cancer. Erlotinib should be administered on an empty stomach.

Drug Availability: erlotinib is supplied as a 25-, 100-, and 150 mg tablet.

PRECAUTIONS:

• ILD: withhold erlotinib for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue erlotinib if ILD is diagnosed

• Renal Failure: monitor renal function and electrolytes, particularly in persons at risk of dehydration. Withhold erlotinib for severe renal toxicity.

• Hepatotoxicity: hepatotoxicity with or without hepatic impairment including hepatic failure and hepatorenal syndrome. Monitor liver function tests and withhold or discontinue erlotinib for severe or worsening liver tests.

• GI perforations: discontinue erlotinib

• Bullous and exfoliative skin disorders: discontinue erlotinib

• Myocardial infarction/ischemia: risk of MI is increased in persons with pancreatic cancer

• Cerebrovascular accident (CVA): the risk of CVA is increased in persons with pancreatic cancer.

• Microangiopathic hemolytic anemia (MAHA): the risk of MAHA is increased in persons with pancreatic cancer.

• Ocular disorders: discontinue erlotinib for corneal perforation, ulceration or persistent severe keratitis.

• Hemorrhage in persons taking warfarin: regularly monitor INR in persons taking warfarin or other coumarin-derivative anticoagulants

• Embryo-fetal toxicity: can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use highly effective contraception.

BILLING/CODING INFORMATION:

HCPCS Coding

C9399

Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

J8999

Prescription drug, oral, chemotherapeutic, NOS

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

C25.0 – C25.3

Malignant neoplasm of pancreas

C25.7 – C25.9

Malignant neoplasm of pancreas

C33

Malignant neoplasm of trachea

C34.00 – C34.32

Malignant neoplasm of bronchus or lung

C34.80 – C34.92

Malignant neoplasm of bronchus or lung

C64.1-C64.9

Malignant neoplasm of kidney, except renal pelvis

C65.1-C65.9

Malignant neoplasm of renal pelvis

C72.0

Malignant neoplasm of spinal cord

C72.1

Malignant neoplasm of cauda equina

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Brachytherapy-Oncologic Applications, 04-77260-20

Denosumab (Prolia™; Xgeva™) Injection, 09-J1000-25

Docetaxel (Taxotere®) IV, 09-J0000-95

Gemcitabine (Gemzar®), 09-J0000-96

Gonadotropin Releasing Hormone Analogs and Antagonists, 09-J0000-48

Intensity-Modulated Radiation Therapy (IMRT), 04-77260-22

Irinotecan HCl (Camptosar®) IV, 09-J0000-99

Magnetic Resonance Angiography (MRA), 04-70540-08

Oxaliplatin (Eloxatin®) IV, 09-J1000-00

Pemetrexed Disodium (Alimta®) IV, 09-J1000-01

Positron Emission Tomography (PET Scans) Oncologic Applications, 04-78000-17

Stereotactic Body Radiotherapy, 02-77371-02

Topotecan HCl (Hycamtin®) IV, 09-J1000-02

Vinorelbine Tartrate (Navelbine®) IV, 09-J1000-03

Zoledronic Acid IV (Reclast®; Zometa®), 09-J0000-72

OTHER:

TABLE 1:

ECOG PERFORMANCE STATUS*

Grade

ECOG

0

Fully active, able to carry on all pre-disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2

Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair

5

Dead

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com Accessed 10/4/2016.
  2. Erlotinib. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 October 4].
  3. Ingenex, HCPCS Level II, Expert 2013.
  4. Ingenex, ICD-9-CM for Physicians – Volumes 1 & 2, Expert 2013.
  5. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 7/5/16.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 7/5/16.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Bone Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/bone.pdf Accessed 7/5/16.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2017. Non-Small Cell Lung Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/nsclc.pdf Accessed 11/5/16.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016. Pancreatic Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/pancreatic.pdf Accessed 7/5/16.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 3.2016. Kidney Cancer. Available at http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf Accessed 7/5/16.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/10/16.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

11/15/12

Review and revision to guideline, consisting of updating position statement, added contraindication section, updated program exceptions, added ECOG PS table, and updated references.

09/15/13

Revision to guideline; consisting of administrative action to add treatment of chordoma to position statement and update coding.

11/15/13

Review and revision to guideline; consisting of revising description section, dosage/administration, and precautions section, updating references.

12/15/14

Review and revision to guideline; consisting of position statement, coding, references

12/15/15

Review and revision to guideline, consisting of updating position statement, decription, references.

09/15/16

Review and revision to guideline, consisting of updating position statement, coding, references.

12/15/16

Revision to guideline; consisting of updating position statement and references.

Date Printed: June 28, 2017: 11:57 PM